Status:
WITHDRAWN
Safety and Efficacy of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy in R/R Acute B Lymphoblastic Leukemia
Lead Sponsor:
Second Affiliated Hospital of Xi'an Jiaotong University
Collaborating Sponsors:
Nanjing Legend Biotech Co.
Conditions:
Refractory B Acute Lymphoblastic Leukemia
Relapse B Acute Lymphoblastic Leukemia
Eligibility:
All Genders
14-60 years
Phase:
PHASE1
Brief Summary
This is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of infusion of dual specificity CD19 and CD22 CAR-T cells in patients with relapsed and refractory ...
Detailed Description
CD19-directed CAR-T cell therapy has shown promising results for the treatment of relapsed or refractory acute B lymphoblastic leukemia. CD19 and CD22 are proteins usually expressed on the surface of ...
Eligibility Criteria
Inclusion
- Written informed consent could be acquired;
- Diagnosed with relapse/refractory acute lymphoblastic leukemia;
- Relapse was defined as recurrence of blast cell(more than 5%) in peripheral blood or in bone marrow or extramedullary involvement;
- Refractory was defined as failed to achieve complete remission after two courses of induction therapy;
- CD19/CD22 postive leukemia cell was confirmed by flow cytometry or immunohistochemistry within 90 days since enrollment in this trial;
- Karnofsky score ≥70;
- Results of pregnant test should be negative, and agree to conception control during treatment and 6 months after CAR-T infusion.
- Adequate organ function: EF≥50%; normal ECG; CCR ≥ 50ml/min or Cr \< 2.0mg/dL or \< 2 times upper limitation of normal; ALT and AST\<5 times upper limitation of normal; Serum bilirubin ≤ 3.0mg/dL; DLCO or FEV1 \> 45% of predict value;
- At least 2 weeks intervals since the last chemotherapy;
- At least 2 weeks intervals since the last anti-GVHD therapy if patients have ever ;
Exclusion
- Patients diagnosed with acute promyelocytic leukemia:t(15;17)(q22;q12);
- Women in pregnancy and lactation;
- Uncontrolled infection, Active HBV or HCV infection, HIV positive or any other deadly bacterial/virual diseases;
- Long term use of systemic corticosteroids(5mg per day for 2 weeks);
- Any other uncontrolled life-threaten diseases;
- Patients with history of anaphylaxis to any drugs;
- With central nervous system (CNS) involvement;
- Patients with GVHD after allo-HSCT who needed immunosuppressive agents ;
- Patients with acute autoimmune diseases such as psoriasis or rheumatoid arthritis;
- Other conditions that principle investigator considered may increase the risk of the patients or interference the results.
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04094766
Start Date
August 1 2017
End Date
August 30 2020
Last Update
November 5 2020
Active Locations (1)
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1
Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710000